MAUDE Adverse Event Report: ENCORE MEDICAL L.P STAR; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure of Implant (1924)

Event Date 10/24/2023

Event Type  Injury  

Manufacturer Narrative

The reason for this revision surgery,on (b)(6) 2023, independent sales representative, submitted a star poly swap revision case sheet to enovis f&a.The case took place at st.Alphonsus regional mc boise on (b)(6) 2023 on a 72 year old male patient.The original implant surgery took place at the same facility in 2021.Per independent sales representative "dr revised this surgery from 2021 (no previous case info available) due to the poly becoming oxidized.The patient began to form cysts around the implant site causing the need for revision and new poly placement." the replacement poly implanted is a 99-0028-11f (revision sliding core star ankle 11mm).The explanted poly was retrieved and will be sent back to exponent for further investigation.There were 5 similar complaints identified for star poly component damage.The previous complaints do not aid in the investigation for this complaint, (b)(4).Dhr review was not conducted due to the complaint part not being returned and the part and lot number remaining unknown.The poly was not returned to the houston site, so visual and dimensional inspection did not occur.Simulated use testing did not occur.Per the reporter, the poly was revised "due to the poly becoming oxidized.The patient began to form cysts around the implant site causing the need for revision and new poly placement".As noted in section 6, (b)(4) is in process to improve the oxidative properties of the poly component.Based on the limited information and the poly not being returned to the houston site, the root cause shall remain as unknown.

Event Description

On 10/24/2023, independent sales representative, submitted a star poly swap revision case sheet to enovis f&a.The case took place at st.Alphonsus regional mc boise on (b)(6) 2023 on a 72 year old male patient.The original implant surgery took place at the same facility in 2021.Per independent sales representative "dr revised this surgery from 2021 (no previous case info available) due to the poly becoming oxidized.The patient began to form cysts around the implant site causing the need for revision and new poly placement." the replacement poly implanted is a 99-0028-11f (revision sliding core star ankle 11mm).The explanted poly was retrieved and will be sent back to exponent for further investigation.

• Brand Name: STAR
• Type of Device: PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 18655992
• MDR Text Key: 334725445
• Report Number: 1644408-2024-00211
• Device Sequence Number: 1
• Product Code: NTG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male